This 2-day (Jan. 29-30, 2024) workshop is part of the Humane Society International (HSI) Project “Accelerate non-animal batch release testing for human vaccines”[1] funded by the Bill & Melinda Gates Foundation.
Within the project, the prioritization of the implementation (or further development) of in vitro opportunities for those vaccines has been highlighted to be a priority by many vaccines manufacturers; and regulatory authorities and NCLs are keen to learn more about those. The project allows stakeholders to have dedicated discussions with experts in the field and join local or global workshops to fill any knowledge gaps and allow additional discussions on prioritizations and resources needed.
The objective of this workshop is to engage all the industry and regulatory stakeholders in a discussion on the possible strategies to facilitate introduction and acceptance of non animal testing strategies (or animal reduction ones) for the batch release of DTwP containing vaccines, whenever scientifically possible.
The workshop is divided in two days to facilitate the participation of the key stakeholders based all over the world. January 29th will be dedicated to the safety testing discussion and January 30th on the potency.
The ease the dialogue the workshop will provide a quick update on the available opportunities, and the ones that are in development, that can substitute the current safety and potency testing strategies. The dialogue will see the attendees to share and reflect about:
- their knowledge on those opportunities,
- their view or experience on the introduction of such opportunities in their local routine testing,
- what it is needed to move towards updating current local regulations, pharmacopoeias and guidance.
Tentative agenda
January 29th – Strategies for updating current animal based safety testing
| Time in CET | Topic | Speaker |
| 11:00-11:10 | 1. Welcome | Laura Viviani, SciEhiQ |
| 11:10- 11:30 | 2. Overview of the opportunities for testing deletion for DTP vaccines | Catherine Milne, EDQM |
| 11:30-12:50 | 3. Overview of the opportunities for testing replacement. 3.1 Diphtheria – Absence of toxin Irreversibility of toxoid: Vero-cells assay (20 min) 3.2 Tetanus toxicity: BINACLE (20 min) 3.3 Tetanus toxicity: cell-based assay opportunity and readiness (20 min) 3.4 The value of the MWGT for wP (20 min) | Pradip Das, Biological E Shahjahan Shaid, GSK Andrew Peden, Ciara Doran, Sheffield University Pradip Das, Biological E |
| 12:50-13:50 | 4. Interactive discussion with speakers and experts and the attendees | All speakers + WHO Norms and Standards for Biologicals (TBC) Moderated by Laura Viviani and Heidemarie Schindl, AGES |
| 13:50-14:00 | 5. Closing remarks | Laura Viviani, SciEthiQ |
January 30th – Strategies for updating current animal based potency testing
| Time in CET | Topic | Speaker |
| 11:00-11:10 | 1. Welcome | Laura Viviani, SciEthiQ |
| 11:10- 11:30 | 2. DT single dilution or not? Pros and cons of an animal reduction opportunity. NCL and manufacturer’s perspectives. (10 mins each) | Morgane Florens, Sciensano Pradip Das, Biological E Sanofi (TBC) |
| 11:30-12:20 | 3. DTaP in vitro potency test 3.1 Multiplex Assay (20 min) 3.2 ELISA Assay (20 min) | Maxime Vermeulen, Sciensano Paul Stickings, MHRA |
| 12:20-12:50 | 4. Manufacturers approaches to implementations. | Sanofi (TBC); Sunil Goel, Serum Institute of India with a DCVMN perspective on future implementation |
| 12:50-13:10 | 5. wP potency test. 5.1 Perspective on future potency testing (10 min) 5.2 wP bacteria characterization (20 min) | Laura Viviani, SciEthiQ Nicholas Mantis, NY State Lab |
| 13:10-13:50 | 7. Interactive discussion with speakers and experts and the attendees | All speakers + WHO Norms and Standards for Biologicals (TBC) Moderated by Laura Viviani and Heidemarie Schindl, AGES |
| 13:50-14:00 | 7. Closing remarks | Laura Viviani, SciEthiQ |
[1] HSI’s project: https://www.afsacollaboration.org/new-assays-implementation-and-acceptance/